BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAKPLUS

    MDR report key: 7257347 · Received February 8, 2018

    Report

    Report Number
    2183608-2018-00003
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 5, 2018
    Report Date
    January 5, 2018
    Manufacturer
    IMMUCOR GTI DIAGNOSTICS, INC.
    Product Code
    MYP
    UDI-DI
    10888234500254
    PMA / PMN Number
    BK140163
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT ((B)(4)) WAS RECEIVED 09 JAN 2018. ON (B)(6) 2017, CUSTOMER TESTED FRESH PATIENT SAMPLE WITH LOT 3005747 OF PAKPLUS AND RECEIVED A NEGATIVE RESULT FOR WELL A. CUSTOMER RECEIVED NEW LOT OF PAKPLUS 3006225 ON (B)(6) 2018. ON (B)(6) 2018, CUSTOMER TESTING WITH LOT 3006225 OF PAKPLUS ON A PATIENT ALIQUOT FROM (B)(6) 2017. THE RESULT FOR WELL A WAS POSITIVE. CUSTOMER ALSO TESTED ANOTHER PATIENT ALIQUOT COLLECTED FROM (B)(6) WITH LOT 3005747 AND WELL A WAS NEGATIVE. TESTING WAS REPEATED ON (B)(6) 2018 USING BOTH LOTS. LOT 3005747 RESULTED IN WELL A NEGATIVE AND LOT 3006225 RESULTED IN WELL A POSITIVE. CUSTOMER REPORTED NEGATIVE RESULTS ON THE PATIENT FROM THE INITIAL TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94996 PAKPLUS PAKPLUS MYP IMMUCOR GTI DIAGNOSTICS, INC. 3006225 10888234500254

    Patients

    Seq Age Sex Outcome Treatment
    1